Legal Navigation for Cancer

(LEGAL-CARE Trial)

Overseen By Stacey A Ingram, MEd, CHES

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-melanoma skin cancer, benign cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Legal Navigation, designed to help people with advanced-stage cancer manage legal issues related to their treatment. The program provides guidance on complex legal topics such as health insurance, disability benefits, and employment rules, aiming to reduce stress and enhance quality of life. The trial seeks individuals diagnosed with new advanced-stage cancer (stages III/IV) who are beginning systemic therapy and may face these legal challenges. Participants will receive support through phone or video calls with an attorney to address their legal needs. The goal is to determine if this support eases life and if it could be effective in other settings. As an unphased trial, this study offers a unique opportunity for personalized legal support, potentially improving quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on legal navigation for cancer patients, not on medical treatments.

What prior data suggests that this legal navigation program is safe for cancer patients?

Research has shown that patient navigation programs, such as the one in the LEGAL-CARE study, are generally safe and easy for participants. These programs assist patients in managing legal and social challenges related to their cancer treatment. Although the LEGAL-CARE study uniquely focuses on legal issues, similar programs have been found to reduce stress and enhance patient well-being. No known negative effects arise from joining these programs, as they primarily provide guidance and support from trained professionals, rather than medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Legal Navigation for cancer patients because it addresses non-medical challenges that can significantly impact treatment outcomes. Unlike standard care that focuses on medical treatment, this approach proactively identifies and resolves legal barriers like health insurance and financial issues through regular consultations with attorneys. By providing legal support, it aims to reduce stress and improve the overall quality of life for patients and caregivers, potentially enhancing the efficacy of medical treatments and patient well-being.

What evidence suggests that this legal navigation program is effective for cancer patients?

This trial will evaluate the impact of legal support on cancer patients. Studies have shown that addressing legal issues can reduce stress and improve the quality of life for cancer patients. Research indicates that problems such as health insurance and financial aid can complicate cancer care. Programs that assist with these legal challenges can lead to better health and reduced stress for patients. Evidence from previous studies suggests that resolving legal issues can facilitate access to necessary treatment. Overall, legal support could effectively help cancer patients overcome these challenges. ^{5 6 7 8 9}

Who Is on the Research Team?

Qasim M Hussaini, MD, MS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

The LEGAL-CARE trial is for cancer patients at the O'Neal Comprehensive Cancer Center who are experiencing legal issues related to their illness, such as problems with disability benefits, employment, health insurance denials, and financial assistance.

Inclusion Criteria

I am 18 years old or older.

My cancer is at an advanced stage and needs treatment that goes throughout my body.

Exclusion Criteria

Hospice encounter in the past year

Unable to complete surveys

I have been diagnosed with a type of skin cancer that is not melanoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Legal Intervention

Participants receive legal navigation to address cancer-related legal barriers, with proactive outreach by an attorney to discuss legal hardships.

6 months

6 proactive legal intervention cycles, with baseline, 3, and 6 months surveys, and additional monthly check-ins

Follow-up

Participants are monitored for changes in legal barriers, quality of life, and healthcare utilization after the legal intervention.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Legal Navigation

Trial Overview This pilot program tests a 'legal navigation' service designed to assist cancer patients in handling legal matters affecting their treatment. The study will evaluate the feasibility of this service and its impact on patient stress levels, quality of life, and healthcare usage.

How Is the Trial Designed?

Group I: Legal Intervention Arm Experimental Treatment 1 Intervention

There will be 6 proactive legal intervention cycles. During each, an attorney will proactively reach out to the patient or caregiver via telephone or video call within the first month of enrollment to identify and address legal barriers in areas such as health insurance, financial, disability insurance, employment, and other (estate planning, advanced directives, life insurance, family law). The attorney will guide patients and caregivers through necessary actions, and provide resolution. Baseline, 3, and 6 months surveys will be collected, as well as additional surveys at the 1, 2, 3, 4, 5, and 6 month check ins with the legal team.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Triage Cancer

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314725/

Nationwide Analysis of Legal Barriers to Cancer Care - PMC This cohort study characterizes legal barriers to cancer care access for which patients with cancer use legal navigation services and ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.275

Evaluating the availability of oncology financial legal ... Amongst all interventions, PNs assisted with financial assistance, transportation, and health insurance, while 1 intervention reported reduced ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33965

Patient navigation to address sociolegal barriers for patients ... The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer- ...

4. scholarship.law.georgetown.edu scholarship.law.georgetown.edu/context/hja_scholarship/article/1000/viewcontent/Unformatted_DRAFT_A_Systematic_Literature_Review_of_the_Legal_Needs_of_People_with_Cancer_and_the_Outcomes_Measured_when_using_a_Medical_Legal_Partnership_Model__1_.pdf

Legal Needs and Health Outcomes for People with Cancer in ... While there is promising evidence for the effectiveness of MLP on a variety of patient outcomes, there have only been a couple systematic reviews of MLP outcome ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review This systematic review provides compelling evidence supporting the value of patient navigation programs in cancer treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10152516/

Patient navigation to address sociolegal barriers for ... The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and ...

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Overall evidence from 43 unique primary studies across nine reviews suggested that patient navigation interventions were effective at reducing ...

8. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/achieving-equity-cancer-care

Part I. Achieving Equity in Cancer Care: The Need for ... In the intervening decades, cancer patient navigation has consistently been demonstrated to improve outcomes; reduce disparities in cancer care ...

9. pressroom.cancer.org pressroom.cancer.org/2022-06-14-National-Navigation-Roundtable-publishes-new-supplement-on-the-role-patient-navigation-plays-in-improving-patient-outcomes

National Navigation Roundtable Publishes New ... Data shows the customized care provided through these programs decreases hospitalizations and intensive care unit admissions; improves timely ...